DOLOPHINE

Product NDC
0054-4218
11-digit product format
000544218
Labeler code
0054
Product ID
0054-4218_564d1a9c-bba9-43ce-9daa-146044cca627
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHADONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
NDA006134
Marketing category
NDA
Marketing start
1947-08-13
Marketing end
0000-00-00
Substance
METHADONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-4218-25EA - Each0054-42187227c5d8-75df-4f5a-962c-d76dcef0de7912012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-4218-2500054421825100 TABLET in 1 BOTTLE, PLASTIC (0054-4218-25) 100 tablet1947-08-130000-00-00NoNoCurrent